Sulfamethoxazole Prophylaxis Duration After Renal Transplantation

NCT07231770 | Recruiting

• 2 other identifiers: USTC-PJP-Pro2023-ky041
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Renal transplantation is the most ideal and effective treatment for end-stage renal disease. Pneumocystis jirovecii pneumonia (PJP) is one of the most common pulmonary infections after renal transplantation, with high morbidity and mortality that seriously affects patients' prognosis and survival. PJP can be prevented with drugs, and trimethoprim-sulfamethoxazole (TMP-SMX) is the first-choice prophylactic agent. However, there is no clear definition of the prophylactic course of TMP-SMX in domestic and international guidelines. Most of the prophylactic durations for PJP are based on the clinical experience of physicians, ranging from 6 to 12 months across different transplant centers. Multiple studies have shown that some patients still develop PJP more than one year after renal transplantation. Previous research by our team found that PJP has a peak incidence around 9 months after renal transplantation, with a second peak occurring between 10 and 15 months. This study aims to adopt a single-center, randomized, parallel-controlled trial design, planning to enroll 450 patients after renal transplantation. It will investigate the impact of different prophylactic courses of TMP-SMX on the incidence of PJP, and explore whether long-term prophylaxis is more reasonable and effective than short-term prophylaxis. Meanwhile, during follow-up, the peak serum concentration of SMZ in patients will be measured to analyze the relationship between SMZ serum concentration and the occurrence of PJP as well as adverse reactions. A clinical prediction model will be constructed to reveal the effective concentration range of TMP-SMX for prophylactic use. This will further optimize the prophylactic regimen, provide practical guidance for clinical practice, reduce the morbidity and mortality of PJP, and improve prognosis.

Conditions

Chest Tightness; Fever

Outcome Measures

Primary Outcomes (1)

• Incidence of PJP

  18 months after the end of treatment

Secondary Outcomes (1)

• adverse reaction rate

  18 month

Study Arms (3)

A group

OTHER

6-month SMZ prophylaxis

Other: Time-driven dosing

B group

OTHER

12-month SMZ prophylaxis

Other: Time-driven dosing

C group

OTHER

18-month SMZ prophylaxis

Other: Time-driven dosing

Interventions

Time-driven dosing OTHER

The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

A group; B group; C group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following conditions to be enrolled: (1) Age: 18-70 years old; (2) Post-renal transplantation; (3) Voluntarily participate in this clinical study, be able to cooperate with researchers to conduct the study, and sign the informed consent form.

You may not qualify if:

• Criteria: Subjects with any of the following conditions shall be excluded from the trial: (1) HIV-positive; (2) History of TMP-SMX allergy; (3) Glucose-6-phosphate dehydrogenase (G6PD) deficiency; (4) Megaloblastic anemia; (5) Multiorgan transplantation; (6) Complicated with tumor; (7) Complicated with connective tissue disease; (8) Pregnant patients.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuqin Jiang

CONTACT

13675605989; xqjiang@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: May 28, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): August 8, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)